US Dept of Labor

Occupational Safety & Health AdministrationWe Can Help

OSHA Hazard Information Bulletins
Radioactive Contamination of Lead Shielding


June 24, 1997

MEMORANDUM FOR:

REGIONAL ADMINISTRATORS

FROM:

  • STEVEN F. WITT
  • Director
  • Directorate of Technical Support

SUBJECT:

  • Hazard Information Bulletin1: Radioactive Contamination of Lead Shielding

The Illinois Department of Nuclear Safety (IDNS) and the Center for Devices and Radiological Health of the Food and Drug Administration (FDA) have brought to our attention that some lead used in shielding is contaminated with radionuclides and that products containing this lead were widely distributed throughout the country.

IDNS coordinated with FDA regarding the nature of the contamination. FDA on June 13, 1997 issued a public health notice entitled "Radioactivity in Radiation Protection Devices" to health care professionals. All compliance and consultative personnel should be aware that certain lead aprons, gonad shields, thyroid shields and other lead devices used by health care employees could be contaminated. FDA health notice is attached for your use and it includes background information and recommendations.

Please distribute this bulletin to all Area Offices, State Plan States, Consultation Project Offices, and appropriate labor and industry groups.

Attachment

June 13, 1997

FDA PUBLIC HEALTH NOTICE
Radioactivity in Radiation Protection Devices

TO: Health Care Professionals

FDA is notifying you that some shielding products used for radiation protection contain lead contaminated with small amounts of naturally occurring radionuclides. The contaminants are lead-210 (Pb-210) and its daughter nuclides bismuth-210 (Bi-210) and poloniurn-210 (Po-210). Initial FDA and state evaluations indicate that there is only a very small exposure to radioactivity from the affected products, and the contaminants are not transferable to patients, personnel or equipment by ordinary use. The products identified to date include medical devices used for radiation protection such as lead aprons, gonad shields, and thyroid shields manufactured after October 1, 1996.

Standard radiation safety practice is to avoid unnecessary exposure to radiation. Therefore the use of contaminated products should be discontinued. However, in cases where no alternative shielding is available, continued use of the contaminated products will be likely to provide greater protection during therapeutic and diagnostic procedures than using no shielding. Facilities which have no alternative protective devices available should consider continued use of the contaminated items until replacements are obtained.

Investigations are underway to identify all firms that received contaminated lead. FDA and state radiation control program officials have determined that a shipment of contaminated tin-lead alloy was imported from Brazil and then processed by MIDCO Industries of St. Louis, MO. MIDCO sold contaminated lead to Taracorp Industries of Granite City, IL. Taracorp then manufactured contaminated lead powder which was sold to 19 firms. Some of these 19 firms manufactured or distributed contaminated lead or lead products to a number of companies, including medical device manufacturers.

Recalls are being initiated by medical device firms and distributors. To date, E-Z-EM of Portchester, NY, and Picker Corporation of Cleveland, OH, are voluntarily recalling contaminated products. Other manufacturer recalls are likely to follow. If you have purchased affected products, you should receive notice from your supplier. The notice should provide instructions for disposition or return of the devices, and may include replacement information. As affected product lists are available, they will be provided to the Conference of Radiation Program Control Directors and posted on the FDA's Internet site.

FDA recommends radiation protection medical devices containing lead purchased after October 1, 1996 be surveyed for radionuclide contamination. This should be done by qualified personnel a suitable survey meter, such as a thin window Geiger Mueller (G-M) instrument in contact with the product. The 1.16 MeV beta from the Bi-210 is easily detected with this type of instrument.

  • If the survey results indicate contamination, contact your supplier for further instructions.
  • If you don't have the capability to survey, contact the supplier of your devices purchased after October 1, 1996, to determine if their products are affected by this problem.
  • If you receive a notice or a customer letter from a manufacturer or supplier concerning this matter, follow the instructions which should include information on disposition of affected products.

FDA is working with state radiation control program officials to identity all contaminated lead products that have been introduced into commercial distribution and to facilitate effective recalls of all contaminated devices. As additional information becomes available, FDA will issue updated notices.

FDA requests users who discover shielding products with contaminated lead to report this information directly to MedWatch, the FDA's voluntary reporting program. Submit these reports to MedWatch by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by mail to:

MedWatch
Food and Drug Administration HF-2
5600 Fishers Lane
Rockville, MD 20857

Contact Sherry Purvis-Wynn of FDA's Center for Devices and Radiological Health by E-mail slp@cdrh.fda.gov or by fax 301-594-2968 if you have any questions about this notice.

Sincerely,

  • D. Bruce Burlington, M.D.
  • Director
  • Center for Devices and Radiological Health

1 The Directorate of Technical Support issues Hazard Information Bulletins (HlBs) in accordance with OSHA Instruction CPL 2.65 to provide relevant information regarding unrecognized or misunderstood health hazards, inadequacies of materials, devices, techniques, and engineering safety controls. HlBs are initiated based on information provided by the field staff, studies, reports and concerns expressed by safety and health professionals, employers, and the public. Information is compiled based on a through evaluation of available facts, literature and in coordination with appropriate parties.

Back to Top

Thank You for Visiting Our Website

You are exiting the Department of Labor’s Web server.

The Department of Labor does not endorse, takes no responsibility for, and exercises no control over the linked organization or its views, or contents, nor does it vouch for the accuracy or accessibility of the information contained on the destination server. The Department of Labor also cannot authorize the use of copyrighted materials contained in linked Web sites. Users must request such authorization from the sponsor of the linked Web site. Thank you for visiting our site. Please click the button below to continue.

Close